U.S. patent application number 11/863684 was filed with the patent office on 2008-04-03 for system and apparatus for rapid stereotactic breast biopsy analysis.
Invention is credited to Peter R. Lafferty.
Application Number | 20080081984 11/863684 |
Document ID | / |
Family ID | 39261890 |
Filed Date | 2008-04-03 |
United States Patent
Application |
20080081984 |
Kind Code |
A1 |
Lafferty; Peter R. |
April 3, 2008 |
SYSTEM AND APPARATUS FOR RAPID STEREOTACTIC BREAST BIOPSY
ANALYSIS
Abstract
A stereotactic breast biopsy apparatus and system that may
comprise an x-ray source, a digital imaging receptor, and a biopsy
specimen cassette, wherein the x-ray source is provided with a
means for displacing the beam axis of the x-ray source from a
working biopsy corridor beam axis to permit an unobstructed
illumination of the biopsy specimen and thereby produce biopsy
x-ray images directly in the procedure room for immediate analysis.
Some examples of the benefits may be, but are not limited to, a
more rapid analysis of biopsy specimen digital images,
post-processing image capability, and decreased procedure time and
diminution of patient bleeding complications and needle
discomfort.
Inventors: |
Lafferty; Peter R.; (New
Albany, OH) |
Correspondence
Address: |
STANDLEY LAW GROUP LLP
495 METRO PLACE SOUTH
SUITE 210
DUBLIN
OH
43017
US
|
Family ID: |
39261890 |
Appl. No.: |
11/863684 |
Filed: |
September 28, 2007 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
60827327 |
Sep 28, 2006 |
|
|
|
Current U.S.
Class: |
600/407 |
Current CPC
Class: |
A61B 10/0096 20130101;
A61B 2010/0225 20130101; A61B 90/17 20160201; A61B 2090/376
20160201; A61B 90/11 20160201; A61B 10/0266 20130101 |
Class at
Publication: |
600/407 |
International
Class: |
A61B 5/05 20060101
A61B005/05 |
Claims
1. An apparatus adapted to be used for rapid stereotactic breast
biopsy specimen analysis, said apparatus comprising: (a) an x-ray
source having means for displacing an x-ray beam axis of said x-ray
source from a first beam axis; (b) means for retention of a biopsy
specimen; and (c) a digital imaging receptor associated with said
means for retention of said biopsy specimen; wherein said x-ray
source is adapted to be positioned to enable an x-ray image of said
biopsy specimen to be formed upon said digital imaging
receptor.
2. The apparatus of claim 1 wherein said x-ray source means for
displacing said x-ray beam axis comprises a slideable track system,
whereby said x-ray beam axis may be laterally displaced from said
first beam axis.
3. The apparatus of claim 1 wherein said x-ray source means for
displacing said x-ray beam axis comprises a rotatable support
system, whereby said x-ray beam axis may be rotationally displaced
from said first beam axis.
4. The apparatus of claim 1 wherein said means for retention of a
biopsy specimen comprises a biopsy specimen cassette.
5. The apparatus of claim 4 wherein said biopsy specimen cassette
comprises a base hingedly attached to a lid, said base comprising
at least one groove for retention of said biopsy specimen within
said specimen cassette.
6. The apparatus of claim 4 wherein said biopsy specimen cassette
comprises a base slidably attached to a lid, said base comprising
at least one groove for retention of a biopsy specimen within said
specimen cassette.
7. The apparatus of claim 1 wherein said digital imaging receptor
is ancillary to a second digital imaging receptor adapted to be
used during collection of a biopsy specimen.
8. The apparatus of claim 7 wherein said ancillary digital imaging
receptor is adjustably connected to said second digital imaging
receptor.
9. The apparatus of claim 7 wherein said ancillary digital imaging
receptor is rigidly connected to said second digital imaging
receptor.
10. An apparatus adapted to be used for rapid stereotactic breast
biopsy specimen analysis, said apparatus comprising: (a) an x-ray
source having means for displacing an x-ray beam axis of said x-ray
source from a working biopsy corridor beam axis to permit x-ray
illumination of a biopsy specimen; (b) a biopsy specimen cassette
adapted to retain a biopsy specimen; and (c) a digital imaging
receptor having a first side facing said x-ray source and means for
retention of said biopsy specimen cassette; wherein said biopsy
specimen cassette is adapted to be positioned between said x-ray
source and said first side of said digital imaging receptor to
permit x-ray images of said biopsy specimen to be formed upon said
digital imaging receptor when subjected to x-ray illumination by
said x-ray source, thereby facilitating rapid stereotactic breast
biopsy analysis.
11. The apparatus of claim 10 wherein said x-ray source means for
displacing said x-ray beam axis of said x-ray source comprises a
slideable track system, whereby said x-ray beam axis may be
laterally displaced from said working biopsy corridor beam
axis.
12. The apparatus of claim 10 wherein said x-ray source means for
displacing said x-ray beam axis of said x-ray source comprises a
rotatable support system, whereby said x-ray beam axis may be
rotationally displaced from said working biopsy corridor beam
axis.
13. The apparatus of claim 10 wherein said digital imaging receptor
is further adapted to be used during collection of a biopsy
specimen.
14. The apparatus of claim 10 wherein said digital imaging receptor
is ancillary to a second digital imaging receptor adapted to be
used during collection of a biopsy specimen.
15. A system adapted to be used for rapid stereotactic breast
biopsy specimen analysis, said system comprising: (a) an x-ray
source having means for displacing an x-ray beam axis of said x-ray
source from a first beam axis; (b) means for retention of a biopsy
specimen; and (c) a digital imaging receptor associated with said
means for retention of said biopsy specimen; wherein said x-ray
source is adapted to be positioned along a second beam axis to
enable an x-ray image of said biopsy specimen to be formed upon
said digital imaging receptor.
16. The system of claim 15 wherein said x-ray source means for
displacing said x-ray beam axis comprises a slideable track system,
whereby said x-ray beam axis may be laterally displaced from said
first beam axis.
17. The system of claim 15 wherein said x-ray source means for
displacing said x-ray beam axis comprises a rotatable support
system, whereby said x-ray beam axis may be rotationally displaced
from said first beam axis.
18. The system of claim 15 wherein said digital imaging receptor is
further adapted to be used during collection of a biopsy
specimen.
19. The system of claim 15 further comprising a second digital
imaging receptor adapted to be used during collection of a biopsy
specimen.
20. The system of claim 19 wherein said digital imaging connector
is attached to said second digital imaging receptor.
Description
[0001] This application is a nonprovisional application of, and
claims priority to, U.S. Provisional Application No. 60/827,327,
filed Sep. 28, 2006, which is incorporated by reference as if fully
recited herein.
TECHNICAL FIELD
[0002] Exemplary embodiments of the present invention relate to
methods (e.g., medical non-surgical) of diagnosing breast cancer
and, more particularly, to a novel apparatus, system, and method
which beneficially improves current stereotactic breast biopsy
devices and methods.
BACKGROUND OF THE ART
[0003] Stereotactic breast biopsy has become the method of choice
for the non-surgical diagnosis of many forms of breast cancer. Many
breast cancers are discovered by the presence of
microcalcifications visible on a screening mammogram. Yet, these
microcalcifications do not have a corresponding palpable
abnormality. Therefore, an image-guided needle biopsy technique
must be utilized to determine if early, pre-invasive breast cancer
is present. Currently, stereotactically guided needle biopsy
procedures represent the state-of-the-art for the common situation
outlined above.
[0004] However, though very safe and minimally invasive,
stereotactic breast biopsy can be laborious, time-consuming and
uncomfortable for the patient. The procedure requires the patient
to be prone. In order to immobilize the breast, physical
compression must be applied to the breast during the procedure, and
the patient must remain motionless. Procedure times are typically
between 30-45 minutes, despite recent advances in vacuum-assisted
biopsy needle technology. A significant component of procedure time
continues to be consumed by the film development cycles required
for specimen radiograph production.
[0005] A specimen radiograph is an ex-vivo x-ray picture of the
biopsy samples or specimen "threads" retrieved from the breast.
Under conventional circumstances, this radiograph must be performed
outside the procedure room on a standard mammography x-ray unit.
This picture is required to assure that sufficient quantities of
microcalcifications are removed from the groups of calcium targeted
within the breast. This process proves that the biopsy procedure
will be adequate for subsequent analysis by surgical pathology. The
process of performing specimen radiography is standard-of-care for
stereotactic breast biopsy. Each specimen radiograph cycle can last
5-10 minutes, thereby adding 20-30% additional procedure time. If
the original specimen radiograph demonstrates a paucity of
microcalcifications, additional biopsy samples must be harvested,
and the specimen radiograph cycle must be repeated.
SUMMARY OF THE INVENTION
[0006] One exemplary embodiment of the present invention is a
modification and improvement to the commercially available
stereotactic biopsy systems (e.g., LORAD Medical Systems Corp.,
Danbury, Conn. or Fischer Medical Technologies, Inc., Denver,
Colo.). This modification may allow the stereotactic, swing-arm
x-ray source (currently used solely to guide the biopsy procedure)
to be used in the rapid production of specimen radiography. In one
exemplary embodiment, a mechanical track may allow the x-ray source
to shift laterally from the working biopsy corridor (occupied by
the patient's breast during a procedure) allowing the x-ray source
beam to be aligned with an add-on digital image receptor card which
may be added to the lateral aspect of the existing image receptor.
The harvested biopsy specimen threads may be positioned in, for
example, specimen slots on a disposable specimen cassette or
holder. The disposable specimen holder may then be attached to the
add-on digital image receptor card between the x-ray source and
digital image receptor card to allow for instant production of
specimen radiographs within the procedure room. Other exemplary
embodiments are possible as set forth herein.
[0007] Some examples of the benefits may include, but are not
limited to, the following:
a) Production of instant digital (rather than analog) specimen
radiographs in the procedure room can be achieved. This feature can
reduce procedure time up to 30%, thereby improving patient
tolerance of the procedure.
[0008] b) Bleeding complications and needle discomfort can be
diminished, as the typical number of samples harvested by the
operator may decrease with exemplary embodiments of the present
invention. There may no longer be a disincentive to "view" the
biopsy sample early in the procedure, after a few samples have been
retrieved.
[0009] c) The digital specimen radiograph can be "post-processed"
(filtered and windowed) to assure adequate visualization of very
small, subtle microcalcifications, (many of which may be less than
0.1 mm in diameter). This feature may improve the accuracy of
stereotactic biopsy. With analog specimen radiography, these types
of microcalcifications can be very difficult to reliably identify,
resulting in the need for additional biopsy retrieval.
d) Decreased procedure time may allow for more procedures to be
performed within a given time and level of staffing commitment.
This may improve the economic viability of this procedure for
biopsy centers.
[0010] These and other advantages may be provided by exemplary
embodiments of the present invention, as described in more detail
below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] Other aspects of exemplary embodiments of the present
invention will be readily apparent from the following descriptions
of the drawings and exemplary embodiments.
[0012] FIG. 1 illustrates an example of a breast biopsy specimen
radiograph showing microcalcifications.
[0013] FIG. 2 illustrates a front perspective view of a typical
stereotactic biopsy system (commercially available from LORAD).
[0014] FIG. 3 illustrates a perspective view of a typical
stereotactic biopsy system (commercially available from LORAD)
showing details of the swing-arm x-ray source subassembly.
[0015] FIG. 4 illustrates a perspective view of a typical
stereotactic biopsy system (commercially available from LORAD)
showing details of the swing-arm x-ray source subassembly.
[0016] FIG. 5 illustrates a perspective schematic view of a typical
stereotactic biopsy system showing exemplary components.
[0017] FIG. 6 illustrates a top plan schematic view of a typical
stereotactic biopsy system showing exemplary components without a
patient table.
[0018] FIG. 7 illustrates a perspective schematic view of an
exemplary embodiment of a stereotactic biopsy system of the present
invention with the x-ray source in a stowed configuration.
[0019] FIG. 8 illustrates a top plan schematic view of an exemplary
embodiment of a stereotactic biopsy system of the present invention
with the x-ray source in a stowed configuration.
[0020] FIG. 9 illustrates a perspective schematic view of an
exemplary embodiment of a stereotactic biopsy system of the present
invention with the x-ray source in a deployed configuration.
[0021] FIG. 10 illustrates a top plan schematic view of an
exemplary embodiment of a stereotactic biopsy system of the present
invention with the x-ray source in a deployed configuration.
[0022] FIG. 11a illustrates a perspective schematic view showing
one example of a specimen cassette with the specimen cover in an
open position.
[0023] FIG. 11b illustrates a perspective schematic view showing
one example of a specimen cassette with the specimen cover in a
partially closed position.
[0024] FIG. 11c illustrates a perspective schematic view showing
one example of a specimen cassette with the specimen cover in a
closed position.
[0025] FIG. 12 illustrates a perspective exploded schematic view
showing one example of a specimen cassette positioned for insertion
onto a digital imaging receptor card.
[0026] FIG. 13 illustrates a perspective schematic view showing one
example of a specimen cassette positioned onto a digital imaging
receptor card.
[0027] FIG. 14 illustrates a perspective schematic view of another
exemplary embodiment of a stereotactic biopsy system of the present
invention.
[0028] FIG. 15 illustrates a top plan schematic view of an
exemplary embodiment of a stereotactic biopsy system of the present
invention with the x-ray source in a rotated configuration.
[0029] FIG. 16 illustrates a top plan schematic view of the present
invention with an x-ray source and digital imaging receptor in
respective stowed configurations.
[0030] FIG. 17 illustrates a top plan schematic view of an
exemplary embodiment of an x-ray source and digital imaging
receptor in respective deployed configurations.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENT(S)
[0031] FIG. 1 illustrates a typical specimen radiograph showing a
needle aspirated biopsy specimen 45 and microcalcifications 55.
Biopsy specimens similar to 45 may be harvested from a patient's
breast 25 typically via a plurality of samples collected from a
target area 35. The specimen radiograph is an ex-vivo x-ray picture
of the biopsy samples retrieved from the breast, which under
conventional circumstances, must be processed outside the procedure
room, on a standard mammography x-ray unit or on a separately
purchased commercially available unit, such as one produced by
Faxitron X-ray Corporation, Wheeling, Ill. In the current state of
the art, this picture is required to assure that sufficient
quantities of microcalcifications are removed from the groups of
calcium targeted within the breast.
[0032] FIGS. 2, 3, and 4 illustrate a typical example of a
commercially available stereotactic biopsy system 10 produced by
LORAD Medical Systems Corp., Danbury, Conn. During a typical biopsy
collection procedure, a patient is positioned in a prone position
on table 20. The patient's breast under examination is allowed to
protrude through a port 30 in table 20 and is captured and
stabilized between a digital imaging receptor 40 and needle stage
50. The x-ray source 60 illuminates the breast with x-ray radiation
forming an image on the digital imaging receptor 40, located on the
distal side of the breast relative to x-ray source 60, for
subsequent image processing. The collected x-ray image is reviewed
and post-processed on a connected computer console and system in
the procedure room. Foundation 80 and base 90 are rotatably
connected which allows the physician to orient the x-ray source 60
and digital imaging receptor 40 to produce stereotactic image pairs
that allow the physician to accurately position the tip of the
biopsy needle (in x, y, and z coordinates) within the patient's
breast.
[0033] Referring now to FIGS. 5 and 6, the x-ray source 60, which
is fixedly attached to foundation 80, projects a radiation beam
along a working biopsy corridor along beam axis 110 (occupied by
the patient's breast during a procedure). During a typical biopsy
harvesting procedure, a specimen radiograph is produced via an
ex-vivo x-ray image of the biopsy samples retrieved from the
breast. Under conventional circumstances, this radiograph must be
performed outside the procedure room on a standard mammography
x-ray unit or on a separately purchased Faxitron unit. This
radiograph is required to assure that sufficient quantities of
microcalcifications are removed from the groups of calcium targeted
within the breast. This process proves that the biopsy procedure
will be adequate for subsequent analysis by surgical pathology.
Each specimen radiograph cycle can last 5-10 minutes, thereby
adding 20-30% additional procedure time. If the original specimen
radiograph demonstrates a paucity of microcalcifications,
additional biopsy samples must be harvested and the specimen
radiograph cycle must be repeated.
[0034] To provide quicker results, an exemplary embodiment of this
invention may beneficially reduce the time needed to conduct the
ex-vivo x-ray image processing steps described heretofore by
allowing the physician to process and review x-ray images within a
procedure room by means of modifications and improvements to, for
example, commercially available stereotactic biopsy systems (e.g.,
LORAD, Fischer Medical Technologies, etc.). An example of this
modification comprises a means by which the stereotactic, swing-arm
x-ray source 60 (currently used solely to guide the biopsy
procedure) may be, for example, displaced or rotated for use in
concert with an image receptor to allow the rapid production of
specimen radiography.
[0035] FIGS. 7 through 11 illustrate an example of one exemplary
embodiment of the present invention wherein a mechanical track
system 65, which may be slidably attached to foundation 80 and
support x-ray source 60, allows the x-ray source 60 to be laterally
displaced from the working biopsy corridor along beam axis 110
(otherwise occupied by the patient's breast during a procedure). An
add-on ancillary digital image receptor 70 is introduced and
preferably positioned adjacent to digital imaging receptor 40,
whereby the now displaced x-ray source beam 120 (shown in FIG. 10)
may be aligned with a digital image receptor 70 to allow x-ray beam
axis 120 to impinge normally upon the ancillary digital image
receptor face 150, such as shown in the example of FIGS. 12 and
13.
[0036] A means for retaining collected biopsy samples within the
apparatus for analysis may be provided by a wide variety of
mechanical support schemes. As shown as one example in FIGS. 11a,
11b, and 11c, harvested biopsy specimens 45 may be positioned in a
specimen "cassette" 130 that may be fixedly or removably attached
to an ancillary digital image receptor 70, which may be, in-turn,
fixedly or removably associated with digital imaging receptor 40.
In one exemplary embodiment, it may be preferable that the specimen
cassette 130 be fabricated of x-ray transparent materials that are
low in cost so as to promote disposability, such as paper-based
materials or plastics, which may include, for example,
polyethylene, polypropylene, polycarbonates, and polystyrenes,
among others. FIG. 11a illustrates one example of a cassette 130
design which comprises a cassette base 180 that is hingedly
attached to a cassette lid 170 via hinges 190. FIGS. 11b and 11c
illustrate one example of a cassette lid 170 closure scheme. Other
cassette base and cassette lid closure schemes are possible. For
example, one exemplary embodiment may include the use of
interlocking tongues and grooves on the cassette base 180 and
cassette lid 170, which may allow for a slideable connection
between cassette lid 170 and cassette base 180 instead of hinges
190. A single or plurality of specimen channels 140 may, for
example, be formed as grooves within cassette base 180. Such
specimen channels may provide cavities by which a single or
plurality of biopsy specimens 45 may be captured within cassette
130 upon closure of cassette lid 170. The cassette 130 may allow
biopsy specimens 45 to be positioned between the x-ray source 60
and ancillary digital image receptor 70 within beam 120, thereby
allowing expeditious and direct biopsy image processing for instant
production of specimen radiographs within the procedure room via a
computer control monitor with consequent benefits heretofore
described.
[0037] FIGS. 12 and 13 illustrate one example of one means by which
cassette 130 may be removably attached to ancillary digital
receptor 70. In this example, flanges 200 may be used to removably
associate cassette 130 with ancillary digital image receptor face
150. Other means to removably associate cassette 130 with the
ancillary digital image receptor face 150 may comprise, but are not
limited to, hook and loop fasteners, contact adhesives, magnets,
tongue and groove connections, mechanical fasteners, and other
similar or suitable means.
[0038] FIGS. 14 and 15 illustrate an example of another exemplary
embodiment wherein the x-ray source 60 is provided with a means to
be rotatably connected about a longitudinal axis to foundation 80,
whereby the x-ray source beam may be rotationally displaced from a
working biopsy corridor beam axis 110 to position 120. In this
example, ancillary digital image receptor 70 may be rigidly or
adjustably associated with digital imaging receptor 40 or with a
convenient point on foundation 80. Support means for x-ray source
60 may allow selective positioning of x-ray beam axis 120 so as to
be normal to the ancillary digital image receptor face 150 shown in
FIGS. 12 and 13 in this exemplary embodiment.
[0039] Other embodiments include, but are not limited to, means of
rotationally and/or laterally displacing the x-ray source about or
relative to any axis or axes to provide sufficient displacement of
an x-ray source beam from a working biopsy corridor beam axis 110
to allow unobstructed x-ray source illumination of a collected
biopsy specimen 45 contained within a specimen cassette 130
associated with an ancillary digital image receptor 70. It should
be further noted that ancillary digital image receptor 70 may be
fixedly or removably attached to a movable and adjustable support
means (e.g., a cart, etc.) separate from (but in a suitable working
vicinity of) a foundation 80 in some exemplary embodiments.
[0040] FIGS. 16 and 17 illustrate an additional embodiment, which
includes a means for laterally and/or rotationally displacing an
x-ray source 60, as heretofore taught, in concert with similar
means for laterally and/or rotationally displacing a digital
imaging receptor 40 to allow sufficient displacement of a radiation
beam axis 120 from a working biopsy corridor 110, thereby allowing
direct use of the digital imaging receptor 40 and eliminating the
need for an ancillary digital image receptor 70. This latter
embodiment may provide a means for capturing and stabilizing a
breast by a breast support plate 160, which may be separately
connected to foundation 80, allowing independent use and free
movement of the digital imaging receptor 40. Furthermore, this
exemplary embodiment may include a biopsy specimen cassette 130
that may be fixedly or removably associated with digital imaging
receptor 40 in a manner similarly taught heretofore.
[0041] While certain exemplary embodiments of the present invention
are described in detail above, the scope of the invention is not to
be considered limited by such disclosure, and modifications are
possible without departing from the spirit of the invention as
evidenced by the following claims.
* * * * *